Home / Recalls / Blue Belt Technologies, Inc / Z-0041-2024

Z-0041-2024 Class II Ongoing

Recalled by Blue Belt Technologies, Inc — Pittsburgh, PA

Recall Details

Product Type: Devices
Report Date: October 11, 2023
Initiation Date: September 7, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56 units

Product Description

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Reason for Recall

CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

Distribution Pattern

US Nationwide distribution.

Code Information

UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689